Woebot for Substance Use Disorders

Phase 1

Completed

• Conditions: Substance Use Disorders

• Registration Number: NCT04096001
• Lead Sponsor: Woebot Health

Brief Summary

Phase 1 of this study aims to develop a digitally-delivered substance use disorder program through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient satisfaction with and the acceptability of W-SUDs as a substance use management tool.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-19
• Study Start: 2020-03-26
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Results First Submitted: 2022-04-28
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Results First Posted: 2022-08-31
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• All genders
• 18-65 years
• Must have access to a smartphone and able to download the W-SUDs app
• Committed to engage with app and complete assessments
• Be willing to provide email address (to distribute incentives)
• Be literate in English (as W-SUDs conversational and video materials will be in English)
• Endorse a substance use concern according to the DAST-10 and/or AUDIT-C scale cutoffs for problematic use

Exclusion Criteria

• Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
• Suicide attempt or within the past year
• Drug or alcohol overdose within the past year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks	Change from Baseline to Post-treatment at 8 weeks	The AUDIT-C is a widely used 3-item self-report screen for hazardous or harmful alcohol consumption that is based off of the 10-item original AUDIT. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks	Change from Baseline to Post-treatment at 8 weeks	The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity.
Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks	Change from Baseline and Post-treatment at 8 weeks	The number of days a substance was used the past 30 days

Secondary Outcome Measures

Name	Time	Method
The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks	Post-treatment at 8 weeks	The CSQ-8 is an 8-item self-report scale measuring satisfaction with treatment. Scores from 8 to 32, with higher values indicating higher satisfaction.
Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks	Post-treatment at 8 weeks	URPI-Acceptability Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Acceptability inquires about intervention acceptability. Responses range from 1= "slightly disagree" to 6="strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.
Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks	Post-treatment at 8 weeks	URPI-Feasibility Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Feasibility inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1= "slightly disagree" to 6="strongly agree". Scores are averages, with greater scores indicating greater intervention feasibility.
Change Pain Rating From Baseline to Post-Treatment at 8 Weeks	Change from Baseline to Post-treatment at 8 weeks	Range from 0-100 (no pain to worst pain imaginable).
Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks	Change from Baseline to Post-Treatment at 8 weeks	Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.
Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks	Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks	Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Scores range from 15-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot".
Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks	Change from Baseline to Post-treatment at 8 weeks	The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% ("not at all confident") and 100% ("totally confident") where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence.
Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks	Change from Baseline to Post-Treatment at 8 weeks	Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.

Trial Locations

Locations (1)

Woebot Labs Inc; 🇺🇸 San Francisco, California, United States